Lupus Intervention for Fatigue Trial (LIFT)

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Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching and group educational sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management group educational sessions.This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Condition or disease

Intervention/treatment

Phase

FatiguePhysical ActivityLupus Erythematosus, Systemic

Behavioral: ExperimentalOther: Control

Not Applicable

Detailed Description:

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching based in motivational interviewing and group educational sessions focusing on physical activity and nutrition while the control group will receive individual calls and group sessions focusing on SLE self-management. This study is designed to evaluate the LIFT intervention to decreased fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

The experimental intervention is a unique combination of four individual counseling sessions based in motivational interviewing and six group educational sessions focusing on physical activity, dietary behavior and behavioral strategies. The individual sessions will provide a tailored personalized intervention including problem-solving and goal setting for increasing physical activity, and following a healthy diet. Healthy Lifestyle Coaches (RN or MPH) will be responsible for conducting the individual and group sessions for a caseload of participants. There are no drugs involved in the intervention.

Behavioral: Experimental

The experimental intervention includes 4 individual coaching sessions (initial 1 hour in-person and remaining 10-15 minutes per telephone) designed to identify barriers and supports for physical activity and nutrition using motivational interviewing. They occur shortly after randomization, 1.5, 3, and 6 months. Daily participants monitor their physical activity via the Fitbit Flex and their dietary behavior on a paper diary. Participants receive 6 consecutive monthly group sessions, beginning shortly after randomization focusing on the following topics: introduction to physical activity; fruits/vegetables; motivation; lifestyle physical activity; healthy diet; and enhancing your environment. The 1 hour sessions are interactive so participants can share information and support each other.

Active Comparator: Control

The control group intervention will receive six group educational sessions focusing on SLE disease management. A nurse practitioner will be responsible for conducting the group sessions.Control arm participants will also receive four individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting approximately 10-15 minutes.

Other: Control

The control group will receive 6 group educational sessions focusing on SLE disease management. Topics include: what is lupus, laboratory tests, medications, taking charge of your health care and managing stress (2 sessions). Sessions will be didactic followed by a brief question and answer period and last about 1 hour. A nurse practitioner will be responsible for conducting the group sessions. Control arm participants receive 4 individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting about 10-15 minutes. They occur shortly before first group session, then at 1.5, 3, and 6 months.

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Layout table for eligibility information

Ages Eligible for Study:

18 Years to 80 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

include meeting at least 4 of 11 American College of Rheumatology (ACR) classification criteria for definite SLE, or 3 out of 11 ACR classification criteria with also meeting at least one SLICC criteria

It is the intent of all investigators in this project to share any and all resources generated as a result of an award for this project. The final data from this project will be de-identified in accordance with HIPAA guidelines.